Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Responsibilities

• Lead the development and execution of the strategy for computer system validation (CSV), regulatory compliance, and sustained inspection readiness.
• Serve as the Technology Regulatory Inspection Lead to ensure alignment with global quality and compliance strategies.
• Drive inspection readiness efforts through playbooks, SME coaching, system documentation, and readiness dashboards.
• Oversee digital platform implementations, including resource management, risk mitigation, and financial oversight.
• Manage digital technology services, focusing on validation, compliance, data integrity, and system reliability.
• Design and implement effective support models and manage vendor and third-party accountability.
• Lead cross-functional teams and present strategic updates to senior leadership.
• Establish performance metrics to drive continuous improvement and operational excellence.

Requirements

• Doctorate degree with 2 years of Information Systems/Technology and/or Engineering experience
• OR Master’s degree with 4 years of experience
• OR Bachelor’s degree with 6 years of experience
• OR Associate’s degree with 10 years of experience
• OR High school diploma/GED with 12 years of experience
• Expertise in computer system validation (CSV)
• Strong knowledge of regulatory compliance and inspection readiness

Preferred Qualifications

• Prior experience in biotechnology, pharmaceutical, or other highly regulated industries.
• Hands-on experience in computer validation and regulatory compliance.
• Ability to translate operational goals into actionable strategies across manufacturing, laboratory, and supply chain functions.
• Strong leadership skills with the ability to influence and collaborate across cross-functional partnerships.
• Excellent verbal, written, and presentation skills for engaging senior management.

Benefits

• Comprehensive health, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models where possible.

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients living with serious illnesses. Since 1980, Amgen has pioneered innovations in oncology, inflammation, general medicine, and rare diseases, leveraging advanced human genetics and biologics manufacturing expertise to improve health outcomes worldwide.